Abata Therapeutics

Senior Director, Late-Stage Readiness Lead

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

The ideal candidate should possess extensive experience in late-stage clinical development, NDA or BLA submissions, and inspection-readiness planning, demonstrating a strong understanding of cross-functional dependencies and resource management. Candidates should also have experience collaborating with various teams including Clinical Development, Biometrics, Clinical Operations, Regulatory, Quality Assurance, Supply Chain, Research & Translational Medicine, and Commercial.

Responsibilities

As the Senior Director, Late-Stage Readiness Lead, you will conduct gap analyses to identify potential risks to trial or submission readiness, drive cross-functional planning and preparation for Phase 3 clinical studies and BLA submissions, regularly report on progress to executive leadership, facilitate communication and problem-solving between functions, and coordinate resources and timelines for preparation activities.

Skills

Late-Stage Clinical Development

BLA/NDA Submissions

Regulatory Readiness

Inspection-Readiness Planning

Cross-Functional Coordination

Leadership in Biotech/Pharmaceuticals

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Key Metrics

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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